Implantable medical system

ABSTRACT

The invention provides an implantable system for managing urinary incontinence. The system includes a sling with an elongate body member having a proximal portion, a distal portion and an intermediate portion. The intermediate portion is configured to be positioned underneath urethra of a subject for providing an adequate support to prevent leakage of urine during a stress event. The system may include a pressure sensor communicatively coupled with the elongated body member and configured to be positioned in an abdominal cavity and adapted to sense an increase in intra-abdominal pressure. The pressure sensor generates a first signal that is indicative of a change in the intra-abdominal pressure upon occurrence of the pressure event. The system includes a processing circuit to process the signal sensed by the pressure sensor. The processing circuit is configured to generate a second signal causing an adjustment of tensioning force in the elongate body member thereby changing magnitude of a supportive force to the urethra.

BACKGROUND Field

The present invention generally relates to medical devices and moreparticularly relates to implantable medical devices and surgicalprocedures for deploying the implantable medical devices in a patient'sbody for repair of urinary incontinence, and methods for functioning ofthe implantable medical devices.

Description of the Related Art

Urinary Incontinence is a medical area of increasing importanceespecially in women. Stress urinary incontinence is a condition in whicha patient leaks urine when a sudden increase in abdominal pressureoccurs. The increase in pressure can occur due to various routineactivities.

Various treatment options have been provided for stress urinaryincontinence. Current treatment options for stress urinary incontinenceinclude surgical as well as non-surgical options. For example,sub-urethral slings may be used to treat stress urinary incontinence bycreating a support to the urethra and bladder neck. A sling tries toincrease urethral closure pressure during stress to mitigate aninvoluntary loss of urine. In this surgical procedure, a sling hangingfrom and secured to pubo-abdominal side is used to support the urethrafrom below.

Though the pubovaginal sling procedures have been effective in returningcontinence to women, but additional support by the slings permanentlyand all the time may cause severe damages such as infection, erosion,irritation etc. The body may reject the slings in some cases. Moreover,the support provided by the slings may not be in accordance withrequirements at a particular instant.

In view of the above, there is a need for an improved medical implantand a medical system for providing adequate support to urethra orbladder neck for repair of urinary incontinence.

SUMMARY

The present invention provides an automatically controlled implantablesystem for managing urinary incontinence. The system includes a slingwith an elongate body member having a proximal portion, a distal portionand an intermediate portion, wherein the intermediate portion isconfigured to be positioned underneath the urethra of a subject forproviding an adequate support to prevent leakage of urine during astress event. The system may further include a pressure sensorcommunicatively coupled with the elongated body member and configured tobe positioned in an abdominal cavity and adapted to sense an increase inintra-abdominal pressure transferred from the abdominal cavity. Thepressure sensor generates a first signal that is indicative of a changein the intra-abdominal pressure upon occurrence of a pressure event. Thesystem further includes a processing circuit to process the signalsensed by the pressure sensor. The processing circuit is configured togenerate a second signal causing an adjustment of tensioning force inthe elongate body member thereby changing magnitude of a supportiveforce to the urethra. In an embodiment, the system may include anelastomeric tube being fabricated monolithically with the elongate bodymember. The tube may include a lumen there-through for allowingcirculation of a fluid, wherein the circulation of fluid allowsadjustments in the tensioning force in response to the second signalreceived from the processing circuit. In an embodiment, the system mayinclude a shape memory polymer member at least one of coupled with andintegrated with the elongate body member. The shape memory polymermember may be configured to deform from an initial state to a secondstate in response to the second signal received from the processingcircuit. The deformation in the shape memory polymer member allows foradjustments in the tensioning force provided to the elongate body memberupon occurrence of the pressure event.

The present invention provides a subject-controlled implantable systemfor managing urinary incontinence. The system may include a urinarysling with an elongate body member having a proximal portion, a distalportion and an intermediate portion. The intermediate portion of theelongate body member is configured to be positioned underneath theurethra of a subject for providing an adequate support to preventleakage of urine during a stress event. The system may include a triggerunit subcutaneously placed and configured to be activated manually by asubject upon his desire arising out of changing abdominal pressurestransferring from an abdominal cavity. The trigger unit may beconfigured to generate a first signal upon activation by the subject.The system may further include a processing circuit to process the firstsignal. The processing circuit is configured to generate a second signalto request an adjustment of tensioning force in the elongate body memberthereby changing magnitude of a supportive force to the urethra. In anembodiment, the system may include an elastomeric tube being fabricatedmonolithically with the elongate body member. The tube may include alumen there-through for allowing circulation of a fluid, wherein thecirculation of fluid allows adjustments in the tensioning force inresponse to the second signal received from the processing circuit. Inan embodiment, the system may include a shape memory element at leastone of coupled with and integrated with the elongate body member. Theshape memory element may be configured to deform from an initial stateto a second state in response to the second signal received from theprocessing circuit. The deformation in the shape memory element allowsfor adjustments in the tensioning force provided to the elongate bodymember upon occurrence of the pressure event.

BRIEF DESCRIPTION OF THE FIGURES

The invention and the following detailed description of certainembodiments thereof may be understood with reference to the followingfigures:

FIG. 1 illustrates a schematic diagram of an implantable system inaccordance with an embodiment of the present invention.

FIGS. 2A and 2B illustrate schematic diagrams of an implantable systemin accordance with an embodiment of the present invention.

FIGS. 3A and 3B illustrate schematic diagrams of implants in accordancewith some embodiments of the present invention.

FIG. 4 illustrates a perspective view of a medical assembly including animplant in accordance with an embodiment of the present invention.

FIGS. 5A and 5B illustrate an implantable medical system positionedwithin a patient's body.

FIG. 6 illustrates a method diagram for operation of an implantablesystem in accordance with an embodiment of the present invention.

FIG. 7 illustrates a schematic diagram of an implantable system inaccordance with an embodiment of the present invention.

FIG. 8 illustrates an implantable system positioned within a patient'sbody in accordance with an embodiment of the present invention.

FIG. 9 illustrates a method diagram for operation of an implantablesystem in accordance with an embodiment of the present invention.

FIG. 10 illustrates a schematic diagram of an implantable system inaccordance with an embodiment of the present invention.

FIG. 11 illustrates a schematic diagram of an implant in accordance withan embodiment of the present invention.

FIG. 12 illustrates a method diagram for operation of an implantablesystem in accordance with an embodiment of the present invention.

FIG. 13 illustrates a schematic diagram of an implantable system inaccordance with an embodiment of the present invention.

FIG. 14 illustrates a schematic diagram of an implantable system inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION

Detailed embodiments of the present invention are disclosed herein;however, it is to be understood that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition).

In some embodiments, the present invention may be implemented in slingssuitable for the treatment of male and female urinary incontinenceemploying a variety of surgical approaches. For example, female pelvicfloor repair slings such as urinary slings may be implanted bytechniques that involve transvaginal, transobturator, suprapubic,pre-pubic, or transperineal exposures or pathways, and male urinaryincontinence slings may be implanted by techniques that involvetransobturator, suprapubic, or transperineal pathways. The disclosedembodiments can be used as fecal incontinence slings which may beimplanted by techniques that involve transvaginal, transobturator,suprapubic or via perineal floor pathways or through other methods ormay be used for other uplift and reconstruction surgeries. In someembodiments, the invention may be implemented in various other devicessuch as sphincters etc used for pelvic floor repair and incontinencerepair.

FIG. 1 illustrates a schematic diagram of an implantable medical system(interchangeably referred to as implantable system or system) 100 inaccordance with an embodiment of the present invention. The implantablesystem 100 may include a pressure sensor 102 positioned in an abdominalcavity, an implant 104 located proximate a target site, a processingcircuit 106 communicatively connected with the pressure sensor 102, andan actuating mechanism 108 operatively or communicatively connected withthe implant 104 and the processing circuit 106.

In accordance with various embodiments, the implant 104 may be a urinarysphincter, a sling such as a mesh-based sling for urinary incontinence,a non-mesh-based sling made of synthetic or natural material for urinaryincontinence.

The pressure sensor 102 may be located in or around or proximate theabdominal cavity and configured to sense an intra-abdominal pressure orpressure changes. For example, the pressure sensor 102 may be configuredto sense intra-abdominal pressure rises above a certain defined valuethat may cause incontinence. The intra-abdominal pressure may rise dueto events or activities such as coughing, laughing, sneezing, or otheractivities hereafter referred to as pressure events or stress events. Inan embodiment, the implantable system 100 may be activated only when astress event or a pressure event occurs such that the pressure sensor102 senses an increase in the intra-abdominal pressure otherwise theimplantable system 100 may remain deactivated when the intra-abdominalpressure is within a defined range or does not pass the defined valuethat may cause urinary incontinence. A user may deactivate theimplantable system 100 to allow voluntary bladder emptying that mayrequire straining and increase in the intra-abdominal pressure bymanually pushing a switch placed subcutaneously or by using a remotecontrol. In an example, the pressure sensor 102 may be mounted to orproximate the bladder or to any other location if that gives a betterreading of the intra-abdominal pressure or variations in theintra-abdominal pressure. The pressure sensor 102 may generate a firstsignal that is indicative of a change in the intra-abdominal pressureupon occurrence of the pressure event. The first signal may be sent tothe processing circuit 106 to process the first signal sensed by thepressure sensor 102. The processing circuit 106 is configured togenerate a second signal based on the first signal such that the secondsignal is sent to the actuating mechanism 108 to cause an adjustment oftensioning force in the implant 104 thereby changing magnitude of asupportive force to the target site, or to cause closing and/or openingat the target site or stimulation of the target site, based on thenature of implant 100 and functioning of the actuating mechanism 108.

In an example, the actuating mechanism 108 may include a stimulator tostimulate tissues at the target site electrically or electronicallybased on variations in the intra-abdominal pressure so as to allowcontraction of the tissues such as proximate the urethra for avoidingleakage of urine during the stress event. In an example, the actuatingmechanism 108 may include an elastomeric tube fabricated monolithicallywith the implant 104 or mounted separately on the implant 104. Theelastomeric tube may include a lumen there-through for allowingcirculation of a fluid such that the circulation of the fluid allowsadjustments in the tensioning force in response to the second signalreceived from the processing circuit 106. In an example, the actuatingmechanism 108 may include a ball valve configured to close or openpassage of urine flow in response to the second signal received from theprocessing circuit 106 based on variations in the intra-abdominalpressure. In an example, the actuating mechanism 108 may include a shapememory polymer member or shape memory alloy member or any other shapememory element configured to deform between a first state and a secondstate in response to the second signal received from the processingcircuit 106. The deformation in the shape memory polymer member or shapememory alloy member or shape memory element may allow for adjustments inthe tensioning force provided to the implant 104 upon occurrence of thestress event. In an example, the actuating mechanism 108 may include alight-induced (also referred to as light responsive interchangeably)shape memory polymer member or a light-induced shape memory alloy memberconfigured to deform between the first state and the second state inresponse to a light beam or photon received from a light source suchthat a deformation in the light-induced shape memory polymer member orlight-induced shape memory alloy member allows for adjustments in thetensioning force provided to the implant 104 upon occurrence of thestress event.

The implantable system 100 may further include other auxiliary units ordevices or components to facilitate interconnections among the variousdevices of the implantable system 100, to provide power supply, and toperform sensing or processing activities. For example, the implantablesystem 100 may include electrical and/or electronic circuitry forinterconnections, switches for turning the system on or off placedsubcutaneously and controlled by a user such as a subject, other controlsystems for allowing patient control functions, other sensors such as asensor for monitoring bladder fullness, bladder emptiness etc,electrodes, resistors, power supply units, transducers, actuationdevices contained in the actuation mechanism 108 (interchangeablyreferred to as actuating mechanism without limitations) for enablingfunctioning of the actuation mechanism 108 and several other devices orcomponents for enabling functioning and performance of the implantablesystem 100 without limitations.

Several embodiments and variants of the implantable system 100 areillustrated and discussed in conjunction with various figures hereafter.

FIG. 2A and FIG. 2B illustrate schematic views of the implantable system100, in accordance with an embodiment of the present invention, whereinthe actuating mechanism 108 includes or is coupled to a plurality ofelastomeric tubes 202 to control adjustment of the tensioning force inthe implant 104 that supports the urethra or bladder neck or proximatetissues. In an example, the elastomeric tubes 202 may be coupled to theimplant 104 removably. In an example, the elastomeric tubes 202 may befabricated monolithically with the implant 104 such that the implant 104and the elastomeric tubes 202 may be fabricated as a single component.Each of the elastomeric tubes 202 may include a lumen there-through forallowing circulation of a fluid that may be received from a reservoir204 communicatively coupled to the elastomeric tubes 202. Theelastomeric tubes 202 are configured to assume a first configuration(also referred to as a first state interchangeably) and a secondconfiguration (also referred to as a second state interchangeably) basedon whether the fluid is flowing through the lumen or not at a particularinstant. In an example, the first configuration may represent anoriginal state of the elastomeric tubes 202 when no fluid is flowingthere-through and the second configuration may represent a deformed orexpanded state when fluid enters in the lumen of the elastomeric tubes202. In some embodiments, amount of fluid flowing there-though maydefine an extent of deformation in the elastomeric tubes 202 andaccordingly the second configuration may assume different statesdepending on the amount of fluid flowing and the deformation in theelastomeric tubes 202. The first configuration and the secondconfiguration may be altered by altering flow of the fluid through thelumen. For example, upon receipt of the fluid from the reservoir 204 andbased on the amount of fluid flowing there-through, the elastomerictubes 202 may expand to a defined extent thereby providing a definedsupport to the urethra or urethral tissues or bladder neck or otherproximate tissues thus preventing flow of urine leakage. The elastomerictubes 202 may regain their shape such as the first originalconfiguration once the fluid is withdrawn back. The delivery and flow ofthe fluid from the reservoir 204 to the elastomeric tubes 202 andwithdrawal of the fluid from the elastomeric tubes 202 back to thereservoir 204 may be controlled by the processing circuit 106 based onthe first signal received from the pressure sensor 102 by the processingcircuit 106 upon sensing of variations in the intra-abdominal pressuresuch that the processing circuit 106 generates and sends the secondsignal to the actuating mechanism 108 based on the first signal so as toregulate the flow of the liquid or any other fluid. The second signalmay trigger the actuating mechanism 108 to regulate the flow of thefluid.

In an example, the actuating mechanism 108 may include a fluid flowcontrol valve 206 operatively coupled to the reservoir 204, a fluid flowsensor 208 for monitoring the amount of fluid flowing through the fluidflow control valve 206 when the valve 206 is in open state, and anactuating device 210 optionally that may include other mechanicaldevices for actuating the flow of the fluid such as a piston cylinderarrangement, shafts, rods, crankshafts, or other devices. When theintra-abdominal pressure rises upon occurrence of the stress event, theprocessing circuit 106 may generate the second signal and cause thefluid flow control valve 206 to open thereby allowing the fluid to flowthrough the elastomeric tubes 202 to provide the supporting force orincrease the tensioning force to provide additional or increasedsupporting force to the urethra or bladder neck or other proximatetissue. The second signal may be indicative of an amount of thesupporting force required by the urethra or other tissues andaccordingly a defined amount of the fluid may be allowed to pass throughthe elastomeric tubes 202 as controlled by the fluid flow sensor 208after which the fluid flow control valve 206 may close automatically.After the intra-abdominal pressure decreases when the stress event isover, the processing circuit 106 may cause the fluid to be withdrawnfrom the elastomeric tubes 202 back into the reservoir 204. Thereservoir 204 may be coupled operatively to an implantable pump 212placed subcutaneously or at other location as appropriate to control thedelivery and withdrawal of the fluid to/from the elastomeric tubes 202based on the second signal. In accordance with various embodiments,various other mechanisms may be provided for the delivery and withdrawalof the fluid to/from the reservoir 204.

In an example, the reservoir 204 may include a port that may be coupledto a needle from externally for injecting the fluid into the reservoir204 or withdrawing the fluid from the reservoir 204 to replace thefluid. The port may be coupled to the reservoir 204. The reservoir 204may be contained in a housing along with the actuating device 210 andthe pump 212. For example, the housing may enclose the reservoir 204, acylinder, a piston coupled to the cylinder, rods and/or cam and/or geararrangements for allowing circulation of the fluid through the pump 212.The volume of the fluid delivered from the reservoir 204 or withdrawnback into the reservoir 204 dictates position and movement of the pistonwithin the cylinder and of the connecting rods. In an embodimentdifferent components of the actuation mechanism 108 may be located inseparate housings.

The reservoir 204 and other components of the actuation mechanism 108may be implanted below the skin. A set of connecting tubes that mayconnect the actuation mechanism 108 with the elastomeric tubes 202 andvarious other communication leads or wires or circuitry for connectingvarious components and sub-components of the implantable system 100 mayextend through tissues just under the skin or deep within the tissuesbased on requirements.

In an embodiment, the elastomeric tubes 202 may be positioned on abottom surface of the implant 104. In an embodiment, the elastomerictubes 202 may be positioned on a top surface of the implant 104. In anembodiment, when the fluid is passed through the elastomeric tubes 202,the elastomeric tubes 202 may extend in diameter thereby pushing theimplant 104 toward the urethra or bladder neck so that the implant 104exerts additional supportive force to the urethra or bladder neck. Oncethe fluid is withdrawn back, the diameter of the elastomeric tubes 202may decrease leading to relaxing of the urethra or bladder neck.

FIG. 3A illustrates an embodiment of the implant 104. The implant 104has a first portion 302, a second portion 304, and a mid portion 306between the first portion 302 and the second portion 304 with a lengthof the implant 104 extending between the first portion 302 and thesecond portion 304 longitudinally. In an embodiment, as illustrated, theimplant 104 is defined as a linear strip of mesh configured to providesupport to the urethra or bladder neck or other tissues. In accordancewith various embodiments, the implant 104 can have a variety of shapessuch as rectangular, square, trapezoidal, and the like.

In some embodiments, the mid portion 306 of the implant 100 is de-tanged(without tangs). The length of the de-tanged section can vary based onsurgical requirements or location of placement inside the patient'sbody. In some embodiments, the first portion 302 and the second portion304 may include tangs such that upon placement of the implant 104, thefirst portion 302 and the second portion 304 of the implant 104 caninteract with bodily tissues to help anchor or retain the implant 104 inposition within the body of the patient. In some embodiments, thede-tanged section can be made by fusing threads or strands of a meshedge together by heat. The de-tanged section may, in some embodiments,prevent unraveling of the implant 104 when in tension and thus limitsits stretch.

In some embodiments, the implant 104 is made of a synthetic materialsuch as a polymeric material and the like. In some embodiments, theimplant 104 includes a polymeric mesh body. The mesh body may comprise achain link fence-like design. In such designs, the fibers or strands ofthe mesh may be woven, linked, or otherwise connected, and may share thestress of a supported load. In some embodiments, the implant 104 mayinclude a polymeric planar body without mesh cells and structures.Exemplary polymeric materials are polypropylene, polyester,polyethylene, nylon, PVC, polystyrene, and the like. In someembodiments, the implant 104 is made of a non-woven polymeric material.In some embodiments, the implant 104 can be made of natural materialssuch as biologic material or a cadaveric tissue and the like.Additionally, in some embodiments, the implant 104 is stretchable andflexible to adapt movements along the anatomy of the human body. In someembodiments, the implant can be made of biodegradable materials. In someembodiments, the implant can be made of non-biodegradable material. Insome embodiments, the implant can be made of medical grade materials.

The implant 104 shown in FIG. 3A can be coupled with elastomeric tubes202 separately. In an embodiment, the elastomeric tubes 202 may beintegrated within a structure of the implant 104 itself. FIG. 3Billustrates an embodiment of the implant 104 in accordance with such anembodiment wherein the elastomeric tubes 202 may be integrated in theimplant 104. As shown, the elastomeric tubes 202 are embedded within theimplant 104 in the form of hexagonal cells. The hexagonal cells-shapedelastomeric tubes 202 may for example be structured as inflatable meshportions such that upon receipt of the fluid, the inflatable meshportions undergoes inflation and causes an increase in the tensioningforce to provide adequate support and tension to the urethra or bladderneck or other tissues. In an embodiment, the elastomeric tubes 202 maybe defined in another shape or may simply be constructed as linearmembers.

In an embodiment, the elastomeric tubes 202 may be positioned on abottom surface 308 of the implant 104. When the fluid is passed throughthe elastomeric tubes 202, the elastomeric tubes 202 may extend indiameter thereby pushing the implant 104 toward the urethra or bladderneck so that the implant 104 exerts additional supportive force to theurethra or bladder neck. Once the fluid is withdrawn back, the diameterof the elastomeric tubes 202 may decrease leading to relaxing of theurethra or bladder neck.

FIG. 4 illustrates a medical assembly 400 in an embodiment. The medicalassembly 400 includes the implant 104, a first sleeve 402, a secondsleeve 404, a tab 406, a first elongate member 408, and a secondelongate member 410. The first sleeve 402 and the second sleeve 404 areconfigured to shield the first portion 302 and the second portion 304 ofthe implant 104. In some embodiments, the first sleeve 402 and thesecond sleeve 404 can be thin wall flat tubes. In some embodiments, thefirst sleeve 402 and the second sleeve 404 are made of polymer and maybe colored for easy visualization. In some embodiments, the first sleeve402 and the second sleeve 404 can be manufactured from an opaque or atransparent plastic film. The transparent plastic film enables visualexamination of the implant 104. In an example, length of the firstsleeve 402 is sufficient to envelop or shield the first portion 302 ofthe implant 104 and length of the second sleeve 404 is sufficient toshield the second portion 304 of the implant 104. In variousembodiments, the first portion 302 is a first end portion of the implant104 and the second portion 304 is the second end portion of the implant104 such that the first sleeve 402 and the second sleeve 404 areconfigured to enclose the first end portion and the second end portionrespectively of the implant 104. In certain embodiments of the presentinvention, the first and the second sleeves 402 and 404 shield only thefirst portion 302 and the second portion 304 of the implant 104 suchthat the mid portion 306 of the implant 104 remains un-shielded. Theun-shielded mid portion 306 is configured to interact to a bodily tissueupon placement. The length of the implant 104 that is shielded with thesleeves 402 and 404 can vary based on requirements.

The medical assembly 400 may also include a first dilator 412 configuredto be coupled to the first sleeve 402, and a second dilator 414configured to be coupled to the second sleeve 404. The first dilator 412and the second dilator 414 are configured to be coupled respectively todistal ends of the first sleeve 402 and the second sleeve 404. In someembodiments, the first dilator 412 and the second dilator 414 arefurther configured to be coupled to a delivery device (not shown). Thedelivery device can be used to facilitate delivery of the medicalassembly 400 including the implant 104 within the patient's body. Insome embodiments, the dilators 412 and 414 are small in diameter.

The medical assembly 400 further includes a tab 416 configured to becoupled to the implant 104. The tab 416 is configured to identify themid portion 306 of the implant 104 and provide for equal length of theimplant 104 on either side of a body tissue.

In certain embodiments, the first elongate member 408 is configured toremovably couple the implant 104 with the first sleeve 402 and thesecond elongate member 410 is configured to removably couple the implant104 with the second sleeve 404. The first elongate member 408 and thesecond elongate member 410 include one of a thread, a medical suture, afilament, a rope, and the like. The first sleeve 402 and the secondsleeve 404 may be configured to be removably coupled to the implant 104with a single elongate member in other embodiments. The sleeves 402 and404 may be removed from the implant 104 by pulling the elongate members408 and 410 thereby removing the sleeves 402 and 404 from the body afterpositioning and placement of the implant 104 in the body at the targetsite. The sleeves 402 and 404 may prevent the implant 104 fromcontaminations and thus may prevent the body from infection.

In embodiments, the implant 104 may include or be coupled to anchors, ortangs or other structures for facilitating positioning and fixation ofthe implant with bodily tissues. In some embodiments, the implant 104may be fixed to tissues using glue, staples, stitches and the like.

FIGS. 5A and 5B illustrate placement of the implantable system 100 ofFIGS. 2A and 2B within a body of a female subject such that the implant104 provides a support underneath the urethra U for controlling leakageof urine. FIG. 5A shows the urethra U in a relaxed state when theelastomeric tubes 202 are not fluid filled. FIG. 5B shows the urethra ina supported state to stop leakage of urine during a stress event byallowing the fluid to fill the elastomeric tubes 202. In accordance withthe embodiments illustrated in FIGS. 2A-2B, and 5A-5B, variousinterconnections shown between various components or sub-systems mayinclude electrical or electronic circuitry or wireless communicationinterfaces. For example, the processing circuit 106, pressure sensor102, actuating mechanism 108, and the implant 104 may communicatethrough wireless mode, wired mode or a combination of both.

In an embodiment, the elastomeric tubes 202 may be connected with thereservoir 202 through hollow tubes that may allow circulation of thefluid. In an embodiment, the processing circuit 106 and the actuatingmechanism 108 may be connected through electrical or electronic leadsconfigured to transmit signals. In an embodiment, the processing circuit106 and the actuating mechanism 108 may communicate through a wirelessmedium. In an example, the pressure sensor 102 may communicate with theprocessing circuit 106 through electric or electronic circuitry. In anexample, the pressure sensor 102 and the processing circuit 106 maycommunicate wirelessly.

In an example, various components of the implantable system 100 may usewires or wireless radiofrequency telemetry to communicate with circuitryoutside the body. In an example, intra-body communication among thevarious components may use conductive properties of the body to enablewireless communication. In an example, the various or at least somecomponents may include or be connected with transmitters and/orreceivers to receive and/or transmit signals from/to the variouscomponents of the implantable system 100 or from/to outside the bodysuch as a remote controller. The implanted transmitters and receiversmay be connected to equipment outside the body using a short wire orwith wireless RF telemetry. In this way, less power may be needed totransmit and/or receive signals.

In an embodiment the implantable system 100 may be alternativelyself-controlled or controlled by one or more local external controlstations, at or near the location of the patient, and/or one or moreremote external control stations, remote from the patient. Either orboth of the local and remote stations may be operated by a person, suchas a patient, a patient facilitator and/or a medical professional, orthe stations may operate automatically. The remote station may includecomponents such as a database for storing information useful formanaging the implantable system 100, a processor, a memory, atransmitting/receiving device and/or wired connection for communicatingwith the one or more components of the implantable system 100, and awireless link or combinations of these.

In an example, a system for the remote communication with theimplantable system 100 may be used. The system may have a client PC thatmay receive data transmitted via internet from a server PC which maycommunicate with the implantable system 100 implanted into the body. Thesystem particularly may permit the remote communication such that one ormore device experts such as physicians and more experienced device usersmay be aware of the communication and provide guidance for subsequentinterpretation and programming of the device.

In an example, a system that may enable high-frequency communicationbetween an external communication device and the implantable system 100or its various components may be used. The implantable system 100implanted in a human patient may be in electrical communication with thepatient by way of multiple leads or wires. Further the implantablesystem 100 may communicate with a standalone or offline programmer viashort-range telemetry technology. The offline programmer may be equippedwith a wand that, when positioned proximal to the implantable system100, may communicate with the implantable system 100 through a magneticcoupling or by any other way.

In an embodiment, the various components of the implantable system 100such as the pressure sensor 102 and the processing circuit 106 maycommunicate over a small bus having a minimum number of electricallyconductive wires. For example, communication information, along withpower and ground, may be provided over two conductive wires. At the sametime, the implantable system 100 may operate by way of an internal powersource, usually in the form of a battery, which may have a limitedamount of available power. Moreover, because replacement of theimplantable system 100 requires surgery to the patient, conservation ofpower is an important consideration. Further a communication unit maycommunicate with the components and send power as well as asynchronizing signal or clock signal to the components. Thecommunication unit may also contain a transceiver to transmit andreceive data over a communication bus. The communication unit may haveprotection networks to protect the implantable system 100 againsttransient voltages and currents.

FIG. 6 illustrates a method diagram for operation of the implantablesystem 100 in accordance with an embodiment of the present invention.The method 600 of operation of the implantable system 100 is nowdescribed hereafter referring to above discussed FIGS. 1-5B. At step602, the method 600 includes sensing a change in the intra-abdominalpressure. In an embodiment, the change in the intra-abdominal pressuremay be sensed by the pressure sensor 102 located in or around orproximate to abdominal cavity. In some other embodiments, the pressuresensor 102 may be placed in or around or proximate to any other bodycavity or to any other location if that gives a better reading of theintra-abdominal pressure or variations in the intra-abdominal pressure.The intra-abdominal pressure may rise due to events or activities,referred to as the pressure events or the stress events as discussedabove.

At step 604, the method 600 includes generating the first signal whenthe intra-abdominal pressure increases beyond a threshold range which isindicative of the pressure or stress event. The first signal generatedby the pressure sensor 102 may be indicative of the change in theintra-abdominal pressure upon occurrence of the pressure or stressevent. The pressure sensor 102 may send the first sensed signal to theprocessing circuit 106 for further processing.

At step 606, the method 600 further includes generating the secondsignal by the processing circuit 106 based on the first signal. Themethod 600 may further include, at step 608, activating the actuatingmechanism 108 in response to the second signal so that the actuationmechanism 108 of the implantable system 100 causes an adjustment of thetensioning force of the implant 104. The tensioning force may beadjusted such that the magnitude of the supportive force to the urethraor bladder neck or other tissues is adequate to control leakage of urineduring the stress event. In accordance with an example, the secondsignal may activate the actuation mechanism 108 of FIGS. 2A-2B so thatthe actuation mechanism 108 may allow controlled circulation of thefluid through the elastomeric tubes 202 for adjustment of the supportiveforce. In accordance with various other embodiments, the actuationmechanism 108 may be different. A few other actuation mechanisms andstimuli to stimulate the actuation mechanisms in accordance withembodiments are discussed elsewhere in the document without limitations.

In accordance with various embodiments discussed herein, the implantablesystem or the implantable medical system 100 or other implantablemedical systems as discussed later in different embodiments may provideseveral benefits. For example, the implantable medical system 100 mayallow the implant 104 to provide only limited support as required at aparticular instant of time based on intra-abdominal pressure variations.Intra-abdominal pressure may not always remain same and at times theintra-abdominal pressure may not be sufficient enough to cause leakage.In such situations, additional support to the urethra or bladder neck bythe implant 104 may not be needed and may be undesirable. In some cases,the support may be needed only when a stress event occurs. In somecases, only a limited support may be needed when a stress event does notoccur which may be lesser than provided otherwise. However, providingthe support by deploying the implant 104 permanently without anyvariations in the tensioning force in view of the intra-abdominalpressure variations at different times may be harmful and undesirableand may even cause damage to tissues such as infection, erosion,contraction, extrusion, bleeding, irritation etc. Further, implants thatare usually deployed conventionally may be tensioned for extremeconditions of stress and intra-abdominal pressures. However, suchextreme conditions may occur only for a fraction of the total timeimplant remains inside the body. The implantable system 100 as providedby the present invention allows to adjust tensioning of the implant 104and provide adequate support only when needed and to an extend that isdesirable. The implant 104 may thus not be required to support theurethra or bladder neck all the time or with same force at all timesthereby allowing bodily tissues to relax and avoid interactions with theimplant 104 when not needed.

FIG. 7 illustrates an implantable system 700 in accordance with anembodiment of the present invention. The implantable system 700 isconfigured to be activated based on a subject's input whenever thesubject senses possibility of leakage of urine or an increase in theintra-abdominal pressure due to the stress event. As shown, theimplantable system 700 includes the implant 104, a triggering unit 702,the processing circuit 106, and the actuating mechanism 108. The implant202 may be similar to as shown in FIGS. 3A, 3B, 4, 5A, and 5B that maybe configured to support urethra, bladder neck, or proximate tissues forpreventing leakage of urine due to incontinence.

The triggering unit 702 may be positioned subcutaneously and may beaccessible and configured to be activated by the subject from externallyto control operation of the implantable system 700 by the subjectvoluntarily. The triggering unit 702 is configured to be accessed by thesubject upon a desire arising out of changing abdominal pressurestransferring from the abdominal cavity. The triggering unit 702 isconfigured to generate the first signal when activated by the subjectmanually. The first signal may be sent to the processing circuit 106 ina manner similar to as discussed above in conjunction with variousembodiments. The processing circuit 106 may generate the second signalin response to the first signal. The second signal may include a requestto be transmitted to the actuating mechanism 108 for causing anadjustment of the tensioning force in an elongate body member of theimplant 104 thereby changing magnitude of the supportive force to theurethra or bladder neck to a defined value on the basis of requirementsby the subject.

The actuating mechanism 108 may include the plurality of elastomerictubes 202, the reservoir 204, the pump 212, the control valve 206, theactuating device 210, and other auxiliary components. In accordance withthe embodiment illustrated in FIG. 7, the implantable system 700 may notinclude a switch similar to the switch discussed in conjunction withFIGS. 2A-2B as the subject may control operation of the implantablesystem 700 by activating the triggering unit 702 manually when desirablesuch as during passage of urine voluntarily the subject may avoidactivation of the implantable system 700 and keep the elastomeric tubes202 in original state with no fluid filled therein. In an embodiment,the positioning and placement of the actuating mechanism 108 may bedifferent slightly from positioning of the actuating mechanism 108 ofFIGS. 2A-2B if required so as to facilitate operation of the embodimentdiscussed herein without deviating from the spirit and scope of thepresent invention.

In an example, the actuating mechanism 108 and the triggering unit 702may be communicatively coupled to the pressure sensor 102 (not shown inFIG. 7). Upon activation of the triggering unit 702 by the subject, thepressure sensor 102 may be adapted to sense the intra-abdominal pressureor variations in the intra-abdominal pressure transferred from theabdominal cavity such that a measure of the sensed intra-abdominalpressure or pressure variations may be used to determine a desiredcontraction or support in urethra or bladder neck or proximate tissuesthat may result in a necessary supportive force to the urethra orbladder neck. In accordance with this embodiment, while the activationof the actuating mechanism 108 may be manually triggered by the subjectwith the use of the triggering unit 702, the pressure sensor 102 mayhowever allow the actuating mechanism 108 to vary degree of thetensioning force based on the sensed pressure, in an example. In otherexamples, the use of the pressure sensor 102 may be completely avoidedand the actuating mechanism 108 may solely function based on activationof the triggering unit 702 so as to cause the implant 104 to assume oneof the two states of the initial first state and the deformed secondstate. The deformed second state is achieved upon activation of theactuating mechanism 108 allowing circulation of the fluid through theelastomeric tubes 202. The actuating mechanism 108 may becommunicatively coupled with the processing circuit 106 and may functionin a manner similar to as discussed in conjunction with various figuresabove to process the first signal received from the triggering unit 702.In an example, the triggering unit 702 and the processing circuit 106may be integrated as a single device. FIG. 8 illustrates a schematicview of positioning of the implantable system 700 of FIG. 7 inaccordance with an embodiment of the present invention. The trigger unit702 may be subcutaneously placed so as to be activated by applying apressure such as by pressing with a hand of a user or subject fromexternally. The activation may contract or provide additional support tothe urethra or bladder neck or proximate tissues in a similar manner asshown in FIG. 5B and prevent leakage of urine. Once the trigger unit 702is deactivated such as by merely removing the applied pressure or byapplying pressure once again that is by pressing the triggering unit 702by hand once again, the support force to the implant 104 may be removedor reduced. In an example, the trigger unit 702 and the processingcircuit 106 may be integrated in a single housing and positioned at thesame location. In an example, as shown in FIG. 8, the processing circuit106 and the trigger unit 702 may be located separately.

FIG. 9 illustrates a method flow diagram for managing the support to theurethra or bladder neck or other tissues by the implant 104 based onuser desire such as during stress events when there is an increase inthe intra-abdominal pressure which may cause leakage of urine ifadequate support is not provided. The method 900 may include, at step902, activating the trigger unit 702 manually by a subject to generatethe first signal. For example, the subject may apply pressure on tissuesfrom externally so that the trigger unit 702 placed subcutaneously maybe activated upon application of the pressure or upon sensing of abiological touch resulting in generating the first signal. The firstsignal may be transmitted to the processing circuit 106. The processingcircuit 106 may process the first signal and generate the second signalin a manner as explained earlier in conjunction with various figures atstep 904. The method 900 may further include, at step 906, activatingthe actuation mechanism 108 in response to the second signal so that theactuation mechanism 108 of the implantable system 700 causes anadjustment of the tensioning force of the implant 104. The tensioningforce may be adjusted such that the magnitude of the supportive force tothe urethra or bladder neck or other tissues is adequate to controlleakage of urine during the stress event. In accordance with an example,the second signal may activate the actuation mechanism 108 so that theactuation mechanism 108 may allow controlled circulation of fluidthrough the elastomeric tubes 202 for adjustment of the supportiveforce. In accordance with various embodiments, the actuation mechanism108 may be different. A few other actuation mechanisms and stimuli tostimulate the actuation mechanisms in accordance with embodiments arediscussed elsewhere in the document without limitations.

In accordance with the embodiments discussed in conjunction with FIGS.7-9, the implantable system 700 may be configured as apatient-controlled or subject-controlled adjustable urinary implantablesystem 700 that may be actuated manually by the subject when the subjectsenses increased intra-abdominal pressure or when the stress eventsoccurs that may cause leakage of urine.

FIG. 10 illustrates an implantable system 1000, in accordance with anembodiment of the present invention. The implantable system 1000includes an implant 1002, the pressure sensor 102, and the processingcircuit 106. The pressure sensor 102 and the processing circuit 106 maybe similar to the pressure sensor 102 and the processing circuit 106discussed in conjunctions with FIGS. 1 and 2A-2B.

FIG. 11 illustrates the implant 1002 in an embodiment of the presentinvention. The implant 1002 may be placed under a bladder neck or amid-urethra or any other location to provide a support platform forcontrolling leakage of urine due to incontinence. The implant 1002 mayinclude an elongate member 1004 with a first portion 1006, a secondportion 1008, and a mid portion 1010 between the first portion 1006 andthe second portion 1008 with a length of the implant 1002, extendingbetween the first portion 1006 and the second portion 1008longitudinally. The mid portion 1010 may be configured to support theurethra or bladder neck or other tissues at a target site. The implant1002 may be similar to the implant 104 discussed in conjunctions withFIGS. 2A-2B except that the implant 1002 may include a shape memoryelement 1012 positioned at the mid portion 1010 of the implant 1002 thatis configured to support the urethra or bladder neck or othertissues/locations. The shape memory element 1012 may serve as anactuating mechanism 1014 as an alternative to the actuating mechanismsof FIGS. 1 and 2A-2B to cause an adjustment of the tensioning force inthe implant 1002 thereby changing magnitude of the supportive force tothe urethra or bladder neck or other target site or tissues.

Referring to FIGS. 10 and 11, the implantable system 1000 is discussedherein. In an example, the shape memory element 1012 may be coupled tothe mid portion 1010 separately. In an example, the mid portion 1010 maybe fabricated with a shape memory material so that the mid portion 1010itself may behave similar to the shape memory element 1012. In anexample, the shape memory element 1012 may be fabricated from a shapememory polymer. In an example, the shape memory element may befabricated from a shape memory alloy.

Examples of suitable shape memory materials that may be used for theshape memory element 1012 may include nickel-titanium alloy,copper-aluminum-nickel alloy, copper-zinc-aluminium-nickel alloy. In anexample, the shape memory element 1012 may be made of Nitinol. In anexample, the shape-memory polymer may in principle be a natural polymer,such as a “biopolymer.” For example, the shape-memory polymer may be aprotein or polysaccharide. Examples of proteins may include zein,casein, gelatin, glutin, serum albumin and/or collagen. Suitablepolysaccharides may be selected, for example, from the group includingalginate, celluloses, dextrans, pullulan, hyaluronic acid, chitosan andchitin. In an example, the shape-memory polymer may be a modifiedbiopolymer. Examples of these may include cellulose derivatives, inparticular, alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers,cellulose esters, nitrocelluloses and chitosan. The alkyl celluloses maybe, for example, methyl cellulose and/or ethyl cellulose. Examples ofsuitable hydroxyalkyl celluloses may include hydroxyl-propyl cellulose,hydroxypropyl methyl cellulose and/or hydroxybutyl methyl cellulose.Other examples of cellulose derivatives that may be used are celluloseacetate, cellulose propionate, cellulose acetate butyrate, celluloseacetate terephthalate, carboxymethyl cellulose, cellulose triacetateand/or cellulose sulfate salts.

In an example, the shape-memory polymer may be a synthetic polymer. Thepossible synthetic polymers may be resorbable or non-resorbablepolymers. Examples of possible synthetic non-resorbable polymers may be,for example, polyphosphazenes, polyamides, polyester amides,polyanhydrides, polycarbonates, polyacrylates, polyalkylenes,polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkyleneterephthalates, polyorthoesters, polyvinyl ethers, polyvinyl esters,polyvinyl halides, polyvinyl pyrrolidones, polyesters, polysiloxanes,polyurethanes, mixtures thereof and/or copolymers thereof. Suitableexamples of non-resorbable polymers may include ethylene vinyl acetate,polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylphenol, polymethyl methacrylate, polybutyl methacrylate, polyisobutylmethacrylate, polyhexyl methacrylate, polyisodecyl methacrylate,polylauryl methacrylate, polyphenyl methacrylate, polyhydroxypropylmethacrylate, polyethyleneglycol methacrylate, polymethyl acrylate,polyisopropyl acrylate, polyisobutyl acrylate, polyoctadecyl acrylate,polyhydroxyethyl acrylate, polyhydroxypropyl acrylate, polybutylacrylate, mixtures thereof and/or copolymers thereof. Suitableresorbable polymers may further include polyhydroxy acids, preferablypolylactides, polyglycolides, polyhydroxybutyric acid,polyhydroxyvaleric acid, polylactide-co-glycolides,polylactide-co-ε-caprolactone, polyglycolide-co-ε-caprolactone,polyamino acids, poly-pseudoamino acids, polyhydroxylalkanoates,polyvinyl alcohols, mixtures thereof and/or copolymers thereof. In anexample, the shape memory element may be fabricated from a shape memoryalloy. Other examples of suitable materials that may be used for theshape memory element 1012 may include nickel-titanium alloy,copper-aluminum-nickel alloy, copper-zinc-aluminum-nickel alloy,stainless steel, and the like.

The shape memory element 1012 may be capable of assuming an expandedconfiguration and an unexpanded configuration based on the second signalreceived from the processing circuit 106 that initiates a stimulus forchanging configuration of the shape memory element 1012. In the expandedconfiguration, the tensioning of the mid portion 1010 may be increasedthereby causing an increase in the supportive force to the urethra,bladder neck or any other tissue. In the unexpanded configuration, themid portion 1010 may be relaxed so as to decrease tensioning in the midportion 1010 or the elongate body member 1004 thereby decreasing thesupportive force or entirely removing the supportive force as desired.In an example, the measure of expanding or unexpanding of the shapememory element 1012 may vary or may be controlled by the processingcircuit 106 in view of a requirement as indicative from theintra-abdominal pressure variations identified through the first signalgenerated by the pressure sensor 102. The functioning of the pressuresensor 102 and the processing circuit 106 may be similar to as discussedin conjunction with FIGS. 1 and 2A-2B. For example, the shape memoryelement 1012 may expand more when the pressure sensor 102 senses ahigher pressure than when a relatively lower pressure is sensed by thepressure sensor 102 during the stress event. The shape memory element1012 may be configured to resume its shape during the unexpandedconfiguration. For example, the shape memory element 1012 may behavelike a resilient membrane.

The pressure sensor 102 may be communicatively coupled with theprocessing circuit 106 and adapted to sense the intra-abdominal pressureor pressure variations transferred from the abdominal cavity. Thepressure sensor 102 generates the first signal that is indicative of theintra-abdominal pressure or a change in the intra-abdominal pressure orpressure variations upon occurrence of the pressure event. Theprocessing circuit 106 may be configured to process the first signal andgenerate the second signal that triggers the stimulus to cause a changein the configuration of the shape memory element 1012 embedded in thesupport mid portion 1010 of the elongate body member 1004 of the implant1002. The stimulus resulting in the change in the configuration of theshape memory element 1012 causes an adjustment of the tensioning forcein the elongate body member 1004 thereby changing magnitude of thesupportive force to the urethra or bladder neck or other tissues at thetarget site. The shape memory element 1012 is configured to change itsconfiguration between the unexpanded configuration and the expandedconfiguration in response to the second signal or the stimulus generatedbased on the second signal. In accordance with the illustratedembodiment, therefore, the present invention allows to automaticallyadjust the supportive force to the target site such as the urethra orbladder neck upon occurrence of the stress event based on automatedsensing of the intra-abdominal pressure variations thereby preventingleakage of urine due to incontinence. The mid portion 1010 (referred toas support portion or support mid portion interchangeably) may remainrelaxed or may provide only limited support most of the time when theintra-abdominal pressure is not large enough to cause leakage thusavoiding unnecessary application of the force to delicate tissues aturethra, bladder neck and the like. This may save the tissues fromdamage such as erosion, extrusion, infection, or from various other sideeffects.

FIG. 12 illustrates a method diagram for operation of the implantablesystem 1000 of FIG. 10 in accordance with an embodiment of the presentinvention. The method 1200 of operation of the implantable system 1000is now described hereafter referring to FIGS. 10-12. At step 1202, themethod 1200 includes sensing a change in the intra-abdominal pressure.In an embodiment, the change in the intra-abdominal pressure may besensed by the pressure sensor 102 located in or around or proximate tothe abdominal cavity. In some embodiments, the pressure sensor 102 maybe placed in or around or proximate to any other body cavity or to anyother location if that gives a better reading of the intra-abdominalpressure or variations in the intra-abdominal pressure. Theintra-abdominal pressure may rise due to events or activities, referredto as the pressure events or the stress events as discussed above. Thesensing of the pressure by the pressure sensor 102 may be performed in amanner similar to as discussed in conjunction with FIGS. 1, 2A-2B, and6.

At step 1204, the method 1200 includes generating the first signal whenthe intra-abdominal pressure increases beyond a threshold range which isindicative of the pressure or stress event. The first signal generatedby the pressure sensor 102 may be indicative of the change in theintra-abdominal pressure upon occurrence of the pressure event or thestress event. The pressure sensor 102 may send the first sensed signalto the processing circuit 106 for further processing.

At step 1206, the method 1200 further includes generating the secondsignal by the processing circuit 106 based on the first signal. Thesteps of 1204 and 1206 may be similar to steps 604 and 606. The method1200 may further include, at step 1208, initiating the stimulus toactivate the shape memory element 1012 associated with the implant 1002in response to the second signal such that activation of the shapememory element 1012 may change configuration of the shape memory element1012 between the unexpanded configuration and the expandedconfiguration. The change in the configuration of the shape memoryelement 1012 may cause an adjustment in the supporting force to theurethra or bladder neck as per requirements. The supporting force may beadjusted such that the magnitude of the supporting force to the urethraor bladder neck or other tissues is adequate to control leakage of urineduring the stress event. In an embodiment, the second signal may be sentby the processing circuit 106 to a stimulating source for changing theconfiguration of the shape memory element 1012 from the unexpandedconfiguration to the expanded configuration when the stress eventoccurs. Once the stress event is over and there is no more increasedintra-abdominal pressure as sensed by the pressure sensor 102, theprocessing circuit 106 may generate a signal again to cause the shapememory element 1012 to regain its unexpanded configuration. For example,the method 1200 may also include generating a signal by the processingcircuit 106 again to change the expanded configuration to the unexpandedconfiguration that allows the shape memory element 1012 to regain itsshape when the intra-abdominal pressure reaches within the thresholdrange after the stress event is over.

In accordance with alternative or various embodiments, the presentinvention may include different ways to stimulate the shape memoryelement 1012 by employing different mechanisms to generate the stimulussuch as different types of stimulation sources.

In an example, as illustrated in FIG. 13, the shape memory element 1012may include conducting shape memory polymer composites with carbonnanotubes that may be configured to be electro-active. FIG. 13illustrates a schematic view of among other things the implant 1002 withsuch a shape memory element 1012 that communicates with the processingcircuit 106 for managing support to the urethra or bladder neck or othertissues by application of an external electric field or electric energyfrom an electric source 1302. The implant 1002 may include a set ofelectrodes communicatively and operatively coupled with the electricenergy source 1302. The electric energy source 1302 may generate anelectric current that may serve as a stimulus to activate theelectro-active shape memory element 1012. The processing circuit 106 maygenerate the second signal that initiates the stimulus and causes theelectro-active polymer composites with carbon nanotubes to respond inaccordance with the second signal. The processing circuit 106 may beprogrammed so as to generate the second signal to request a change inthe configuration of the shape memory element 1012 from the unexpandedconfiguration to the expanded configuration when the stress event occursand the pressure sensor 102 senses the increased intra-abdominalpressure. The processing circuit 106 may further be programmed togenerate a signal again so as to request a change in the configurationof the shape memory element 1012 from the expanded configuration to theunexpanded configuration after the stress event is over and the urethraor bladder neck may not need any support or may require reduced support.In alternative embodiments, the shape memory element 1012 or shapememory polymer may include dielectric susceptible components other thanthe carbon nanotubes. The shape memory element 1012 may comprisebiodegradable shape memory polymers or alloys or non-biodegradablepolymers or alloys.

In examples, the conducting shape memory polymer composites with shortcarbon fibers (SCFs), carbon black and metallic Ni powder, apart fromthe carbon nanotubes as discussed above, may be used. These conductingshape memory polymer composites may be developed by chemicallysurface-modifying multi-walled carbon nanotubes (MWNTs) in a mixedsolvent of nitric acid and sulphuric acid, with the purpose of improvinginterfacial bonding between the polymers and conductive fillers in anembodiment. The shape-memory effect in these types of shape memorypolymers may have been shown to be dependent on filler content and thedegree of surface modification of the MWNTs, with the surface modifiedversions exhibiting good energy conversion efficiency and improvedmechanical properties. The electro-active polymers may be characterizedby their ability to expand and contract, such as a volumetric change, inresponse to electrical stimulation as generated by the electric source.Electro-active polymers may be divided into two categories such aselectronic electro-active polymers (driven by an electric field) andionic electro-active polymers (involving mobility or driven by diffusionof ions). Electronic electro-active polymers (electrorestrictive,electrostatic, piezoelectric, ferroelectric polymers) may be induced tochange their dimensions by applied electric fields. Examples ofmaterials in this class may include ferroelectric polymers, (commonlyknown polyvinylidene fluoride and nylon), dielectric electro-activepolymers, electrorestrictive polymers such as the electrorestrictivegraft elastomers and electro-viscoelastic elastomers, and liquid crystalelastomer composite materials wherein conductive polymers may bedistributed within their network structure. The ionic electro-activepolymers may include ionic polymer gels, ionomeric polymer-metalcomposites, conductive polymers and carbon nanotube composites. Theinduced displacement of both electronic electro-active polymers andionic electro-active polymers may be geometrically designed to bend,stretch, contract or rotate. The ionic electro-active polymers may bendsignificantly upon application of a small voltage, such as 1 or 2 volts,and thereby facilitate proper design of a substrate.

The ionic electro-active polymers may possess a number of additionalproperties that may make them ideal, for use in the implantable devicesof the present invention. In an example, the ionic electro-activepolymers may be lightweight, flexible, small and easy to manufacture.Further the energy sources may be available, which may be easy tocontrol, and thereby the energy may be easily delivered to theelectro-active polymers. In other example, the ionic electro-activepolymers may show small changes in potential (e.g., potential changes onthe order of 1 volt). Furthermore the ionic electro-active polymers maybe used to effect volume change in the electro-active polymers. In anexample, the ionic electro-active polymers may be relatively fast inactuation (e.g., full expansion/contraction in a few seconds).

In accordance with the embodiments discussed above in conjunction withFIGS. 10-13, the implantable system 1000 may be activated automaticallybased on automatically sensing of the intra-abdominal pressure orpressure variations by the pressure sensor 102. In other embodiments,however, the implantable system 1000 may be controlled by the subjectwhen there is a possibility of leakage of urine such as due to increasedabdominal pressure and/or due to occurrence of the stress event. In suchembodiments, the implantable system 1000 may include a trigger unitsimilar to the trigger unit 702 discussed in conjunctions with variousfigures that may be activated manually by the subject. The trigger unitwhen activated may generate the first signal which may cause theprocessing circuit 106 to generate the second signal and initiate thestimulus to activate the shape memory element 1012 for changing itsconfiguration. In accordance with an embodiment of the trigger unitdiscussed in conjunction with various figures, the trigger unit may besubcutaneously placed or may be provided externally such as in the formof a programmer or a controller.

In an example, as illustrated in FIG. 14, the shape memory element 1012may include light induced or photoresponsive shape memory polymersconfigured to be activated by a light beam or photon ejected from alight energy source 1402. FIG. 14 illustrates a schematic view of amongother things the implant 1002 with such a shape memory element 1012 thatcommunicates with the processing circuit 106 for managing support to theurethra or bladder neck or other tissues by application of light energyor photon from the light energy source 1402. The light-induced orphotoresponsive shape memory element 1012 is coupled with or integratedwith the elongate body member 1004 of the implant 1002 such that theshape memory element 1012 is configured to deform from an initial stateto a deformed state (the unexpanded state to the expanded state) inresponse to the light beam or photon. The deformation in the shapememory element 1012 allows for adjustments in tensioning force providedto the elongate body member 1004 upon occurrence of the pressure event.The light energy source 1402 may generate the light beam or photon thatmay serve as the stimulus to activate the photoresponsive shape memoryelement 1012. The processing circuit 106 may generate the second signalthat causes to initiate the stimulus or eject a photon or light beamwhich eventually causes the photoresponsive shape memory element 1012 torespond in accordance with the second signal. The processing circuit 106may be programmed so as to generate the second signal to request achange in the configuration of the shape memory element 1012 from theunexpanded configuration to the expanded configuration when the stressevent occurs and the pressure sensor 102 senses the increasedintra-abdominal pressure. The processing circuit 106 may further beprogrammed to generate a signal so as to request a change in theconfiguration of the shape memory element 1012 from the expandedconfiguration to the unexpanded configuration after the stress event isover. The shape memory element 1012 may comprise biodegradable shapememory polymers or alloys or non-biodegradable polymers or alloys. In amanner similar to as discussed above, in some embodiments, thephotoresponsive shape memory element 1012 may be activated by theprocessing circuit 106 based on the first signal generated by thetrigger unit manually instead of automated detection of pressurevariations and automated adjustment of the supportive force.

The photoresponsive shape memory element 1012 implanted in a patient'sbody may be heated non-invasively using, for example, light energysources such as infrared, near-infrared, ultraviolet, microwave and/orvisible light sources. The light energy may be selected to increaseabsorption by the shape memory element and reduce absorption by thesurrounding tissue. Thus, damage to the tissue surrounding the shapememory element 1012 may be reduced when the shape memory element 1012 isheated to change its shape. Energy absorbing materials for light orlaser activation energy may include nanoshells, nanospheres and thelike, particularly where infrared laser energy is used to energize thematerial. Such nanoparticles may be made from a dielectric, such assilica, coated with an ultra thin layer of a conductor, such as gold,and be selectively tuned to absorb a particular frequency ofelectromagnetic radiation. Coatings comprising nanotubes ornanoparticles can also be used to absorb energy from the light energysource or inductive heating, or the like.

Suitable photosensitive networks or materials or polymers to be used inthe shape memory element 1012 may be amorphous and may be characterizedby covalent network points, which may determine the configurations ofthe shape memory element 1012. The shape memory polymers with aphotosensitive induced shape memory effect, which may respond to aparticular wavelength of light as the transition stimulus, may havephoto-reactive groups, which may reversibly be linked with one anotherby irradiation with light. These photo-reactive groups may take over thefunction of the switching segment in the shape memory polymers withthermal transitions. The programming of a temporary shape andre-generation of the permanent shape may take place by irradiationwithout a change in temperature. Non-limiting examples ofphotoresponsive switches may include cinnamic acid and cinnamylideneacetic acid.

In accordance with various embodiments, the implants discussed inconjunction with various figures above may be implanted through atransvaginal or an abdominal approach or any other approach. In someembodiments, the implants can be used to suspend various bodilylocations in a body of a patient such as pelvic organ of a patient'sbody. In some embodiments, the implants can be used in a urinary sling.In some embodiments, the implants can be used in a retropubicincontinence sling. In some embodiments, the implants can be configuredto be delivered by way of a transvaginal approach or a transobturatorapproach or vaginal pre-pubic approach or a laparoscopic approach or canbe delivered through other methods and may be positioned at variouslocations within a patient's body without limitations.

The implant as discussed in various embodiments herein such as 104 maybe delivered inside a patient's body through a surgical procedure. Insome embodiments, the implant 104 is inserted inside the body through alaparoscopic approach. For example, the method may include creating anabdominal incision for delivering the implant 104 inside the bodylaparoscopically. In some embodiments, the implant 104 is deliveredthrough a transvaginal approach. The procedure may include placing theimplant 104 at a target site underneath the urethra or bladder neck sothat the intermediate portion such as 306 supports the urethra.Subsequently, after the procedure is complete, bodily incisions may beclosed after appropriate tensioning and fixation of the implant 104. Themethod may include making two contra lateral abdominal incisions. Themethod may further include making a vaginal incision. Other componentsof the implantable system such as 100 may be deployed inside the bodythrough various incisions at various locations. For example, thepressure sensor 102 may be placed in the abdominal cavity in anembodiment. The processing circuit 106 and the actuating mechanism 108may be placed subcutaneously in an embodiment. The implants andimplantable systems as discussed in conjunction with various otherfigures throughout the document may be deployed in a similar manner orin any other manner without limitations.

In accordance with some embodiments, the shape memory element 1012 maybe activated to change its configuration between the expandedconfiguration and the unexpanded configuration through various otherstimuli. For example, in an embodiment, the shape memory element 1012may be activated by a magnetic field or electro-magnetic field. Inexample, the shape memory element 1012 may be triggered upon applicationof an external stimulus including one or more of a temperature change,electric or magnetic field, light, pH and solution such as water-drivenactuation of shape memory polymers. In other examples, varioustransition stimuli such as IR radiation, NIR radiation, UV radiation andthe like, may be radiated to the shape memory polymer. The shape memoryelements with polymers with a thermally induced shape memory effect mayrespond to a thermal transition stimulus which may have at least oneswitching segment with a transitional temperature. The switchingsegments may form temporary cross linking portions, which may resolvewhen heated above the transitional temperature and which form again whenbeing cooled. At this temperature, the shape memory polymer may show achange in shape. In addition, other external stimuli may trigger thetransition between shapes, such as moisture.

In accordance with some embodiments as discussed above in conjunctionwith various figures, the implantable system such as 100 or 1000 mayinclude various other types of implants. The implant may be for examplean artificial urinary sphincter (also referred to as sphincter for thepurpose of simplicity of description without limitations). Theartificial urinary sphincter may be a cylindrical shape structureconfigured to be positioned to a target site for preventing leakage ofurine. The sphincter may include an outer cuff having inner and outerportions for positioning proximate urethra. The sphincter may include aninner shape memory element cuff fabricated from a shape memory polymeror shape memory alloy encircling the inner portion of the outer cuff andconfigured to be directly in contact with the urethra. The shape memoryelement cuff may be electro-conductive in an example. The pressuresensor 102 as discussed above may be communicatively coupled with theinner shape memory element cuff and the outer cuff and adapted to sensethe intra-abdominal pressure transferred from an abdominal cavity orintra-abdominal variations. The pressure sensor 102 may generate thefirst signal that is indicative of a change in the intra-abdominalpressure upon occurrence of a pressure event. The processing circuit 106processes the first signal sensed by the pressure sensor 102 andgenerates the second signal causing to contract the inner cuff to causecompression in the urethra. The inner shape memory element cuff isconfigured to deform from an initial state to a deformed state inresponse to the second signal received from the processing circuit. Adeformation in the inner shape memory element cuff may allow foradjustments in tensioning force or may contract urinary passage uponoccurrence of the pressure event. In an example, the inner shape memoryelement cuff may include conducting shape memory polymer composites withcarbon nano-tubes that may be configured to be electro-active. Thecompression or deformation in the sphincter may be automaticallycontrolled through the sensed intra-abdominal variations in an example.In an example, activation of the sphincter may be controlled manually bya user based on requirements such as with the use of a trigger unitsimilar to the trigger unit 702 discussed earlier. The trigger unit 702may be subcutaneously placed and configured to be activated manually bya subject upon his desire arising out of changing abdominal pressurestransferring from an abdominal cavity or out of other physiologicalconditions. The trigger unit 702 may be configured to generate the firstsignal upon activation by the subject. The processing circuit 106 maygenerate the second signal based on the first signal. The inner shapememory element cuff may be configured to deform from the initial stateto the deformed state in response to the second signal received from theprocessing circuit 106 such that the deformation in the cuff allows foradjustments in the tensioning force provided to the urethra or may allowcontracting of urinary passage upon occurrence of the pressure event.

In accordance with an embodiment, the sphincter may be communicativelycoupled to a light source that may emit a light beam or photon uponreceipt of the second signal from the processing circuit 106. The innershape memory element cuff may be fabricated from a light-induced shapememory polymer or alloy and coupled with the outer cuff or formedmonolithically along with the outer cuff. The inner shape memory elementcuff is configured to deform between the initial state and the deformedstate in response to the light beam or photon originated from the lightsource. The light source may be similar to as discussed earlier inconjunction with various figures.

While the invention has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present invention isnot to be limited by the foregoing examples, but is to be understood inthe broadest sense allowable by law.

What is claimed is:
 1. An automatically controlled implantable systemfor managing urinary incontinence, the system comprising: a sling withan elongate body member having a proximal portion, a distal portion andan intermediate portion, wherein the intermediate portion is configuredto be positioned underneath the urethra of a subject for providing anadequate support to prevent leakage of urine during a stress event; apressure sensor communicatively coupled with the elongated body memberand configured to be positioned in an abdominal cavity and adapted tosense an increase in intra-abdominal pressure transferred from theabdominal cavity, the pressure sensor generating a first signal that isindicative of a change in the intra-abdominal pressure upon occurrenceof the pressure event; a processing circuit to process the signal sensedby the pressure sensor, wherein the processing circuit is configured togenerate a second signal causing an adjustment of tensioning force inthe elongate body member thereby changing magnitude of a supportiveforce to the urethra; and an elastomeric tube being fabricatedmonolithically with the elongate body member, the tube including a lumenthere-through for allowing circulation of a fluid, wherein thecirculation of fluid allows adjustments in the tensioning force inresponse to the second signal received from the processing circuit. 2.The implantable system of claim 1 further comprising a memory circuit tostore values of intra-abdominal pressure associated with differentstates of incontinence including a threshold value which defines stateof leakage of urine, wherein the processing circuit is configured tocorrelate the values with the sensed intra-abdominal pressure todetermine amount of the supporting force required to be provided to theelongate body member to prevent leakage during the stress event.
 3. Theimplantable system of claim 1, wherein the stress event comprises atleast one of coughing, laughing, and sneezing.
 4. The implantable systemof claim 1 further comprising a subcutaneously located manuallyactivating switch configured to deactivate and re-active the implantablesystem by the subject to allow voluntary bladder emptying that requiresstraining and an increase in the intra-abdominal pressure such that theprocessing circuit does not generate the second signal when theimplantable system is deactivated.
 5. The implantable system of claim 1further comprising a reservoir containing the fluid that is placedsubcutanously and accessible from externally to inject or remove thefluid through a port defined in the reservoir, wherein the reservoirfurther includes a sensor configured to monitor amount of fluid flow andallow a defined amount of the fluid to flow through the elastomeric tubefrom the reservoir based on the second signal such that the definedamount of fluid flow provides an adequate increase in the supportingforce to prevent leakage of urine during the stress event.
 6. Theimplantable system of claim 5, wherein the reservoir is operativelycoupled to a pump that allow circulation of the fluid from the reservoirto the elastomeric tube, and withdrawal of the fluid from theelastomeric tube back to the reservoir based on the second signalgenerated by the processing circuit depending on the sensed pressure inthe abdominal cavity by the pressure sensor during the stress event. 7.The implantable system of claim 1, wherein the elastomeric tube isdefined as a hexagonal-shaped honeycomb structure with hollowpassageways for carrying the fluid during circulation, wherein thehexagonal-shaped honeycomb structure is configured to assume theexpanded configuration when the fluid flows there-through such thatexpanded state provides an increased supporting force to the urethrathat is dependent on an amount of flow of the fluid through thehexagonal-shaped honeycomb structure.
 8. The implantable system of claim7, wherein the hexagonal-shaped honeycomb structure is provided on abottom surface of the elongate body member such that an expansion in thehexagonal-shaped honeycomb structure exerts a force toward the bottomsurface of the elongate body member causing a change in the supportingforce to the urethra.
 9. The implantable system of claim 7, wherein theexpanded configuration causes a change in dimension of thehexagonal-shaped honeycomb structure such that the dimensional changesincreases diameter of the hexagonal-shaped honeycomb structure therebypushing the elongate body member toward the urethra so that the implantexerts additional supportive force to the urethra.
 10. The implantablesystem of claim 1, wherein the elongate body member is fabricated as amesh-based structure.
 11. The implantable system of claim 10, whereinmesh fibers of the mesh-based structure are defined hollow in naturewith lumen there-through that are configured to allow circulation of thefluid for adjustment of the tensioning force to provide adequatesupporting force to the urethra based on sensing of increasedintra-abdominal pressure by the pressure sensor, the hollow mesh fibersconfigured as monolithically designed elastomeric tube with the elongatebody member.
 12. The implantable system of claim 10, wherein themesh-based structure is fabricated from a synthetic material.
 13. Theimplantable system of claim 10, wherein the mesh-based structure isfabricated from a biologic material.
 14. The implantable system of claim1 further comprising: a sleeve configured to removably couple a firstend portion of the elongate body member; a second sleeve configured toremovably couple a second end portion of the elongate body member; a tabmember configured to facilitating location of the medial portion of theelongate body member during placement; a first dilator coupled to thefirst end portion of the elongate body member; and a second dilatorcoupled to the second end portion of the elongate body member.
 15. Theimplantable system of claim 1, wherein the elongate body member isdelivered within the body and positioned underneath the urethra througha transvaginal approach.
 16. The implantable system of claim 1, whereinthe elongate body member is delivered within the body and positionedunderneath the urethra through a transobturator approach.
 17. Asubject-controlled implantable system for managing urinary incontinence,the system comprising: a mesh-based urinary sling with an elongate bodymember having a proximal portion, a distal portion and an intermediateportion, wherein the intermediate portion of the elongate body member isconfigured to be positioned underneath the urethra of a subject forproviding an adequate support to prevent leakage of urine during astress event; a trigger unit subcutaneously placed and configured to beactivated manually by a subject upon his desire arising out of changingabdominal pressures transferring from an abdominal cavity, the triggerunit configured to generate a first signal upon activation by thesubject, a processing circuit to process the first signal, wherein theprocessing circuit is configured to generate a second signal to requestan adjustment of tensioning force in the elongate body member therebychanging magnitude of a supportive force to the urethra; and anelastomeric tube being fabricated monolithically with the elongate bodymember, the tube including a lumen there-through for allowingcirculation of a fluid, wherein the circulation of fluid allowsadjustments in the tensioning force in response to the second signalreceived from the processing circuit.
 18. The subject-controlledimplantable system of claim 17 further comprising a pressure sensorcommunicatively coupled with the processing circuit and adapted to senseintra-abdominal pressure transferred from the abdominal cavity uponactivation of the trigger unit manually by the subject, the processingcircuit configured to correlate a value of the sensed intra-abdominalpressure with a defined value of the intra-abdominal pressure that isrepresentative of a necessary supportive force to the urethra, todetermine a desired change in the intra-abdominal pressure for adjustingit to the defined intra-abdominal pressure.
 19. An automaticallyadjustable implantable system for managing urinary incontinence, theimplantable system comprising: a sling having an elongate body memberwith a proximal portion, a distal portion and an intermediate portion,wherein the intermediate portion is configured to be positionedunderneath the urethra of a patient; a pressure sensor communicativelycoupled with the elongated body member and adapted to senseintra-abdominal pressure transferred from an abdominal cavity, thepressure sensor generating a first signal that is indicative of a changein the intra-abdominal pressure upon occurrence of a pressure event; aprocessing circuit to process the first signal sensed by the pressuresensor, wherein the processing circuit is configured to generate asecond signal causing adjustment of a tensioning force in the elongatebody member thereby changing magnitude of a supportive force to theurethra; and a shape memory polymer member at least one of coupled withand integrated with the elongate body member, wherein the shape memorypolymer member is configured to deform from an initial state to a secondstate in response to the second signal received from the processingcircuit, wherein the deformation in the shape memory polymer memberallows for adjustments in the tensioning force provided to the elongatebody member upon occurrence of the pressure event.
 20. The automaticallyadjustable implantable system of claim 19, wherein the shape memorypolymer member includes conducting shape memory polymer composites withcarbon nanotubes that are configured to be electro-active, wherein atransition between the initial state and the second state is triggeredby an electric stimulus that activates the shape memory polymercomposites.
 21. A subject-controlled implantable system for managingurinary incontinence, the system comprising: an elongate body memberwith a proximal portion, a distal portion and an intermediate portion,wherein the intermediate portion is configured to be positionedunderneath the urethra of a patient; a trigger unit subcutaneouslyplaced and configured to be activated manually by a subject upon hisdesire arising out of changing abdominal pressures transferring from anabdominal cavity, the trigger unit configured to generate a first signalupon activation by the subject, wherein the first signal includes arequest for causing an adjustment of tensioning force in the elongatebody member; a processing circuit to process the first signal, whereinthe processing circuit is configured to generate a second signal torequest an adjustment of tensioning force in the elongate body memberthereby changing magnitude of a supportive force to the urethra; and ashape memory polymer member at least one of coupled with and integratedwith the elongate body member, wherein the shape memory polymer memberis configured to deform from an initial state to a second state inresponse to the second signal received from the processing circuit,wherein the deformation in the shape memory polymer member allows foradjustments in tensioning force provided to the elongate member uponactivation of the trigger unit by the subject manually.
 22. Anautomatically-controlled implantable system for managing urinaryincontinence, the system comprising: an elongate body member with aproximal portion, a distal portion and an intermediate portion, whereinthe intermediate portion is configured to be positioned underneath theurethra of a patient; a pressure sensor adapted to sense intra-abdominalpressure transferred from an abdominal cavity, the pressure sensorgenerating a first signal that is indicative of a change in theintra-abdominal pressure upon occurrence of a pressure event; aprocessing circuit communicatively coupled with the pressure sensor toprocess the first signal sensed by the pressure sensor, wherein theprocessing circuit is configured to generate a second signal causingadjustment of a tensioning force in the elongate body member therebychanging magnitude of a supportive force to the urethra; a light sourcecommunicatively coupled with the processing circuit for emitting a lightbeam or photon upon receipt of the second signal from the processingcircuit; and a light-induced shape memory polymer member at least one ofcoupled with and integrated with the elongate body member, wherein thelight-induced shape memory polymer member is configured to deform froman initial state to a second state in response to the light beam orphoton, wherein the deformation in the light-induced shape memorypolymer member allows for adjustments in the tensioning force providedto the elongate member upon occurrence of the pressure event.
 23. Asubject-controlled implantable system for managing urinary incontinence,the system comprising: an elongate body member with a proximal portion,a distal portion and an intermediate portion, wherein the intermediateportion is configured to be positioned underneath the urethra of apatient; a trigger unit subcutaneously placed and configured to beactivated manually by a subject upon his desire arising out of changingabdominal pressures transferring from an abdominal cavity, the triggerunit configured to generate a first signal upon activation by thesubject, wherein the first signal includes a request for causing anadjustment of tensioning force in the elongate body member; a processingcircuit to process the first signal, wherein the processing circuit isconfigured to generate a second signal in response to the first signalto request an adjustment of the tensioning force in the elongate bodymember; and a light source communicatively coupled with the processingcircuit for emitting a light beam or photon upon receipt of the secondsignal from the processing circuit; and a light-induced shape memorypolymer member at least one of coupled with and integrated with theelongate body member, wherein the light-induced shape memory polymermember is configured to deform from an initial state to a second statein response to the light beam or photon, wherein the deformation in theshape memory polymer member allows for adjustments in the tensioningforce provided to the elongate member thereby changing magnitude of asupportive force to the urethra upon activation of the trigger unit bythe subject manually from outside of the body.